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back (Title Page) forward (Introduction) Table of Contents EXECUTIVE SUMMARY Electroconvulsive Therapy (ECT) is a procedure that continues to be the subject of serious controversy and disagreement. even within the psychiatric profession. ECT entails sending an electrical current into the brain of a patient to produce a grand mal epileptic seizure. It has been used for many years to treat certain types of mental illnesses. primarily as a last resort when all other treatment modalities failed. More recently, the New York State Office of Mental Health has encouraged the use of ECT as an initial or mid-level treatment option. The New York State Assembly's most recent examination of the issue of ECT began in February, 200 1. On February 14. 2001 at a public hearing in Syracuse, New York regarding the proposed closing of the Hutchings Psvchiatric Center, a presenter discussed the case of Paul Henri Thomas, then a patient at Pilgrim Psychiatric Center who had been receiving ECT against his will. The Assembly subsequently became aware of the case of Adam S., another patient at Pilgrim P.C. who was a recipient of ECT therapy against his wishes and those of his family. Since the State Legislature had not conducted a formal review of ECT use in New York State since the mid-1970s, the Assembly scheduled hearings in New York City on May 18, 2001 and in Albany on July 18. 2001. The purpose of the first hearing was to determine the incidence of ECT use in the State, its efficacy, benefits and risks, and to examine issues- related to informed consent and involuntary court ordered ECT. The second hearing was held to obtain feedback on the initial series of proposed legislation addressing ECT introduced by the Assembly. It was clear from testimony received that there was a wide variation of opinion related to the use of ECT. Proponents claimed that ECT is a safe, effective procedure with no permanent adverse side cited a figure of 1 in 10,000 deaths related to ECT to document its safety. In contrast, opponents maintained that ECT causes brain damage, can result in permanent memory loss and, in some cases death, and asserted that the death rate related to ECT was closer to I in 200. Opponents expressed additional concerns about the utilization of ECT on children, the elderly, other vulnerable populations and possible use as a behavior modifying, non-therapeutic intervention for mentally retarded individuals. Currently, there is no regulation of ECT protocols by the State or federal governments. However, the federal Food and Drug Administration (FDA), which has regulatory authority over ECT devices, considers ECT machinery to be experimental, Class III devices. Such a classification is used for premarket approval for medical devices that show an unreasonable risk of illness or injury. Although the FDA has never completed testing of ECT devices to determine its safety, ECT has been in use since the 1930's. In addition to the public hearings. New York State Assembly Mental Health Committee Chairman, Martin A. Luster. and Committee staff met with proponents and opponents of ECT, as well as representatives from the State Office of Mental Health (OMH), Office of Mental Retardation and Developmental Disabilities (OMRDD), Commission on Quality of Care for the Mentally Disabled (CQC), and the Mental Hygiene Legal Service (MHLS). Committee staff also reviewed extensive literature regarding ECT. The Committee sought Information regarding the prevalence of ECT use within the State and found there were no available statistics. The Committee requested the CQC complete a survey of ECT use in State operated psychiatric centers. The CQC found that protocols varied at the five State-operated psychiatric centers that perform ECT. CQC recommended that OMH establish a Blue Ribbon Task Force to develop procedures for consistent application throughout State facilities administering ECT use, while simultaneously promoting the application of best practices and strict adherence to statutory and regulatory standards for safeguarding patient rights. The Committee has requested the CQC complete another survey of ECT use in non-state operated facilities. The results of this survey are not yet complete. Moreover, the Committee requested the MHLS provide statewide statistics on applications for court orders authorizing ECT. In April 2001, the MHLS reported a 73% increase in such applications between 1999 and 2000. On May 17. 2001, in a written response to the Committee's initial public hearing notice, the MHLS identified concerns with respect to the current practices for obtaining consent for ECT. The Committee also reviewed the American Psychiatric Association's (APA) 2001 Task Force report, The Practice of Electroconvulsive Therapy, Recommendations for Treatment, Training, and Privileging, Second Edition, which delineated issues related to the education and training of ECT practitioners, procedures for obtaining informed consent, standards for ECT administration and safety of ECT equipment. The Task Force report further identified certain equipment that should no longer be used to provide ECT and expressed concern that ECT facilities be properly equipped and staffed with personnel to manage potential clinical emergencies. During its review, the Committee uncovered instances where ECT had been administered with equipment that the APA stated should no longer be used and on an outpatient basis in physician offices where emergency equipment and staff were unavailable. Article VII of the New York State Constitution states that the aid, care and support of the needy are public concerns (Section One), that the protection and promotion of the health of the State's inhabitants are also matters of public concern (Section Three) and that the care and treatment of persons suffering from a mental disorder or defect, as well as the protection of the mental health of inhabitants may be provided by State and local authorities in such manner as the Legislature may from time to time determine (Section Four). In an effort to mitigate identifiable areas of concern, the Assembly has introduced five legislative proposals to ensure proper use and administration of ECT: 1. Resolution 2097 - Resolution calling upon the United States Congress to require the FDA to determine safety of ECT equipment and to pass legislation establishing proper protocols and administration of use. 2. A.9081 - Defines capacity as well as procedures for assessing a patient's mental capacity in supplying consent for ECT treatment. Requires written disclosure of benefits, risk and alternatives as a component of authorized (i.e. signed) informed consent. 3. A. 9082 - Creates a temporary advisory council on ECT to address associated issues, including but not limited to education and training of ECT practitioners on standards for administration and equipment safety. 4. A. 9083 - Requires mandatory reporting of information regarding ECT use to enable the OMH Commissioner to better regulate its application and help ensure that the Legislature effectively exercise its constitutional oversight function. 5. A. 9084 - Mandates all facilities practicing ECT to provide accessible emergency treatment. |
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